NCT04507880Unknown不适用
A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
Signe Rosner Rasmussen0 个研究点目标入组 42 人开始时间: 2020年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 主要终点
- Change in Constant score (CS)
研究概览
简要总结
The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution
- •Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older.
- •All patients, regardless of age, with an insufficient or irreparable rotator cuff
排除标准
- •Brachial plexus palsy
- •Previous ipsilateral fracture of clavicula, scapula, or proximal humerus
- •Cognitive disabilities or substance abuse enabling rehabilitation and follow-up
- •Patients without a Danish civil registration number
结局指标
主要结局
Change in Constant score (CS)
时间窗: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
The CS consists of four parameters (pain, mobility, ADL, strength) assessing shoulder function after the treatment of shoulder injury, both subjectively and objectively. The scale rates from worst (0) to best (100) quality of shoulder function.
次要结局
- Change in Oxford Shoulder Score (OSS)(The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery)
- Change in EQ5D questionnaire(The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery)
- Change in Numeric Ranking Scale(The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery)
- Change in humeral tuberosities(The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery)
- Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS)(The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery)
- Complications(The outcome is registered 2 years after surgery)
研究者
Signe Rosner Rasmussen
MD, orthopedic resident, principal investigator
Herlev and Gentofte Hospital
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